Principal Investigator/Program Director (Last, First, Middle): SUAREZ-ALMAZOR, Maria E. DESCRIPTION: See instructions. State the application's broad, long-term objectives and specific aims, making reference to the health relatedness of the project (i.e., relevance to the mission of the agency). Describe concisely the research design and methods for achieving these goals. Describe the rationale and techniques you will use to pursue these goals. In addition, in two or three sentences, describe in plain, lay language the relevance of this research to public health. If the application is funded, this description, as is, will become public information. Therefore, do not include proprietary/confidential information. DO NOT EXCEED THE SPACE PROVIDED. Consumers' knowledge, values, and preferences are being recognized as drivers of health care utilization. With the therapeutic advances in the last decades, there are usually multiple options for a given clinical problem with different risk-benefit ratios; yet, patients spend less and less time with their physicians, and often get information from alternate sources, such as the media or direct-to-consumer advertising. We propose the creation of a comprehensive interdisciplinary Patient Awareness and Consumer Education Research Center with an overarching vision of supporting and empowering consumers of healthcare through informed decision-making. The mission of the RC will be to develop a program of excellence to improve consumers' awareness of the benefits and risks of therapeutics through research, education, and dissemination, targeting consumers and their providers. Our strategic plan for the next five years has the following specific aims: Aim 1 To establish the infrastructure for an interdisciplinary RC of excellence to conduct and support research and educational initiatives related to health communication for patients and consumers. Aim 2 To develop a comprehensive research program to evaluate methods, application and outcomes of health communication strategies. This aim will be achieved by: (i) Developing the methodological infrastructure to support investigator-initiated efforts in these areas (e.g. assistancewith grant proposals, collaborative efforts, contribution of resources); (ii) Conducting four demonstration projects Aim 3 To establish a Consumer Health Advisory Information Network (CHAIN) to deploy a system for rapid response to emerging therapeutic issues. Aim 4 To disseminate and implement the information developed by the RC. These operationalaims will be achieved through the creation of three cores within the RC: (i) Research and Training Core; (ii) Methods Core; and (iii) Education and Dissemination Core (including CHAIN). We have identified four major themes which will guide our strategic research, education and dissemination plan: (i) Health communication and consumer education; (ii)Clinician-patient interactions; (iii) Health decision-making; and (iv) Patient adherence to therapeutic recommendations. PERFORMANCE SITE(S) (organization, city, state) Michael E. DeBakey VA Medical Center, Houston, TX Baylor College of Medicine, Houston TX PHS 398 (Rev.09/04) Page 2 Form Page 2 Principal Investigator/Program Director (Last, First, Middle): SUAREZ-ALMAZOR, KEY PERSONNEL. See instructions. Use continuation pages as needed to provide the required information in the format shown below. Start with Principal Investigator. List all other key personnel in alphabetical order, last name first. Name eRA Commons User Name Organization Role on Project Suarez-Almazor, Maria E. Baylor College of Medicine Principal Investigator Crouch, Michael Baylor College of Medicine Demonstration Project 1 Investigator Fordis, Michael Baylor College of Medicine Co-Investigator Giordano, Thomas Baylor College of Medicine Demonstration Project4 Investigator Haidet, Paul Baylor College of Medicine Demonstration Project 2 Investigator Kallen, Michael Baylor College of Medicine Co-Investigator Krishnamurthy, Partha. University of Houston Consutlant Kuo, Grace Baylor College of Medicine CHAIN Investigator Naik, Aanand Baylor College of Medicine Demonstration Project 2 Investiaator Ross Michael University of Texas School Consultant of Public Health Stanley, Melinda Baylor College of Medicine Co-Investigator Street, Richard Texas A&M University Consultant Whitney, Simon Baylor College of Medicine Co-Investigator & Demonstration Project 3 Invfistiaatnr OTHER SIGNIFICANT CONTRIBUTORS Name Organization Role on Project See Section J of application (letters of support). Biographical Sketches accompany letters of support. Human Embryonic Stem Cells Q No d Yes If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the following list: http://stemcells.nih.gov/reqistrv/index.asp. Usecontinuation pages as needed. If a specific line cannot be referenced at this time, include a statement that one from the Registry will be used. Cell Line Disclosure Permission Statement. Applicable to SBIR/STTR Only. SeeSBIR/STTR instructions. [U Yes |~l No PHS 398 (Rev. 09/04) Page 3 Form Page 2-continued Number the following pages consecutivelythroughout the application. Po not use suffixes suchas 4a, 4b. Principal Investigator/Program Director (Last, First, Middle): SUAREZ-ALMAZOR, Maria E. The name of the principal investigator/program director must be provided at the top of each printed page and each continuation page. RESEARCH GRANT TABLE OF CONTENTS Page Numbers Face Page . 1 Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells Table of Contents Summary Detailed Budget for Initial Budget Period Summary Budget for Entire Proposed Period of Support Budgets Pertaining to Administrative Core, CHAIN, and Demonstration Projects Biographical Sketch - Principal Investigator/Program Director (Not toexceed four pages) 29 Other Biographical Sketches (Not to exceed four pages for each- Seeinstructions) 33 Resources.. 69 Research Plan . 74 Introduction to Revised Application (Not to exceed 3 pages) '.. Introduction to Supplemental Application (Not to exceed one page) ; A. Specific Aims 74 B. Background and Significance 75 C. Preliminary Studies/Progress Report/ ^_ (Items A-D: notto exceed 25 pages*) 82 Phase I Progress Report (SBIR/STTR Phase II ONLY) j * SBIR/STTR Phase I: Items A-D limited to 15 pages. 0. Research Design and Methods 86 E. Human Subjects Research 104 Protection of Human Subjects (Required if Item 4 on the Face Page is marked "Yes") 104 Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "Yes" and a Phase I, II, or III clinicaltrial is proposed) Inclusion of Women and Minorities (Required if Item 4 on the Face Page is marked "Yes" and is Clinical Research) 104 Targeted/Planned Enrollment Table (for new and continuing clinical research studies) 105 Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") : 104 F. Vertebrate Animals 109 G. Literature Cited , 109 H. Consortium/Contractual Arrangements : 119 1, Resource Sharing 120 J. Letters of Support 120 Consultants 121 Institutional Support w/Biographical Sketches 124 Other Collaborators with Biographical Sketches 156 Patient Advocates 169 Commercialization Plan (SBIR/STTR Phase II and Fast-Track ONLY) .... Checklist 171 Appendix (Five collatedsets. Nopage numbering necessary forAppendix.) Check if Appendix is Included Appendices NOT PERMITTED for Phase I SBIR/STTR unless specifically solicited Number of publications and manuscripts accepted for publication (not to exceed 10) 10 Other items (list): 1. Publications 2. Research Grants 3. Conceptual Framework & DemonstrationProjects 4. VisionTree Software PHS 398 (Rev. 09/04) Page 4 Form Page 3